January 18, 2011 – The first endovascular device approved for the treatment of pulmonary embolism (PE) was granted CE-mark approval this week in Europe. The Ekos EkoSonic Endovascular System was originally designed and approved to dissolve blood clots in the arms and legs.

January 19, 2011 – The U.S. Food and Drug Administration (FDA) this week granted market clearance for Cook Medical’s Formula balloon-expandable renal stent system. The approval includes both the Formula 414RX Renal and the Formula 418 Renal stents.

January 13, 2011 – A catheter that removes emboli and thrombi from vessels in the coronary and peripheral vasculature has received 510(k) clearance from the U.S. Food and Drug Administration. The Xpress-Way RX manual extraction catheter is manufactured by Kaneka Corp. and distributed by Atrium Medical in the United States.

January 13, 2011 – The first patients have been enrolled in a trial evaluating the effectiveness and safety of a force-sensing ablation catheter for treating symptomatic paroxysmal atrial fibrillation (AF). The TOCCASTAR trial will study Endosense’s TactiCath force-sensing ablation catheter.

January 13, 2011 – Enrollment has finished for the ORION trial designed to test the Epic self-expanding nitinol stent to treat iliac artery disease.

The trial will examine rates of device- and/or procedure-related major adverse events and patency rates at nine months in 125 patients at 28 sites in the United States.

January 13, 2011 – HeartWare International has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration for its ventricular assist system. The system acts as a bridge to heart transplantation for patients with end-stage heart failure.

January 13, 2011 – St. Joseph's Hospital in Tampa, Fla., and the Baylor Jack and Jane Hamilton Heart and Vascular Hospital in Dallas, Texas, are among the first U.S. hospitals to treat patients with atrial fibrillation (A-fib) using a new freezing balloon technology. The minimally-invasive catheter system is the first of its kind in the United States and was approved by the U.S.

January 13, 2011 – A new robotic navigation system has both received the CE mark and undergone its first successful cardiac ablation procedure. The Vdrive robotic navigation system, from Stereotaxis, provides a companion to magnetic navigation.

January 12, 2011 – A new, next-generation vascular closure device has been launched in the United States. The Mynx Cadence Vascular Closure Device (VCD), from AccessClosure, offers physicians smoother device deployment while maintaining all the benefits of the original Mynx.

January 12, 2011 – The Society for Cardiovascular Angiography and Interventions (SCAI) has published a paper on the future trends and developments in the cardiac catheterization laboratory and interventional vascular suite.

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